Pulpotomy in Mature Permanent Molars Using Biodentine Versus MTA

Symptomatic Irreversible Pulpitis Clinical Trial

Official title:

Comparative Evaluation of Postoperative Pain and Success Rate After Pulpotomy in Mature Permanent Molars Using Biodentine Versus Mineral Trioxide Aggregate (MTA) as Capping Materials: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03890835
• Other study ID #: CEBD-CU-2019-03-10
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2019
• Est. completion date: May 2020

Study information

• Verified date: March 2019
• Source: Cairo University
• Contact: Youssef A. Kamal Elalfy, B.D.S
• Phone: +201286069484
• Email: Youssef_Andraws[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare treatment outcomes of pulpotomy in mature permanent teeth using Biodentine versus MTA regarding postoperative pain and success rate.

Description:

• Patients will be clinically and radiographically examined and their eligibility will be assessed.

• Eligible patients will be randomly assigned to one of 2 groups: experimental group (pulpotomy using Biodentine) and the control group (pulpotomy using MTA).

• After adminsrtation of local anesthesia, pulpotomy will be done under rubber dam isolation. The pulp tissue will be removed until the level of the orifices of the canals. After hemostasis is achieved, the capping material will be placed. In the experimental group, the capping material is Biodentine while in the control group, the capping material is MTA

• The cavities will be sealed with resin-modified glass ionomer. Then the teeth will be permanently restored with composite . A post-operative radiograph will be taken.

• The patients will be given a pain diary based on Numerical Rating Scale (NRS) and asked to rate their pain level at the specified times.

• The patients will be recalled after 6 and 12 months post-operatively.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Patients aging between 18-40 years old

• Patients with symptomatic irreversible pulpitis.

• Radiographically: Absence or slight widening in periodontal ligament space.

• Systemically- healthy patients (ASA I or II).

• Patients who agree to attend for recall appointments and provide written consent.

Exclusion Criteria:

• Severe marginal periodontitis.

• Necrotic pulp, pulp polyp, tooth tender to percussion, clinical progression into periapical abscess, fistula.

• Non-restorable teeth, teeth with internal/external root resorption or root canal calcification.

Related Conditions & MeSH terms

• Pulpitis
• Symptomatic Irreversible Pulpitis

Intervention

Procedure:
• MTA Pulpotomy.
Pulpotomy using MTA.
• Biodentine Pulpotomy
Pulpotomy using Biodentine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (3)

Asgary S, Eghbal MJ, Fazlyab M, Baghban AA, Ghoddusi J. Five-year results of vital pulp therapy in permanent molars with irreversible pulpitis: a non-inferiority multicenter randomized clinical trial. Clin Oral Investig. 2015 Mar;19(2):335-41. doi: 10.1007/s00784-014-1244-z. Epub 2014 Apr 27. — View Citation

Bakhtiar H, Nekoofar MH, Aminishakib P, Abedi F, Naghi Moosavi F, Esnaashari E, Azizi A, Esmailian S, Ellini MR, Mesgarzadeh V, Sezavar M, About I. Human Pulp Responses to Partial Pulpotomy Treatment with TheraCal as Compared with Biodentine and ProRoot MTA: A Clinical Trial. J Endod. 2017 Nov;43(11):1786-1791. doi: 10.1016/j.joen.2017.06.025. Epub 2017 Aug 16. — View Citation

Galani M, Tewari S, Sangwan P, Mittal S, Kumar V, Duhan J. Comparative Evaluation of Postoperative Pain and Success Rate after Pulpotomy and Root Canal Treatment in Cariously Exposed Mature Permanent Molars: A Randomized Controlled Trial. J Endod. 2017 Dec;43(12):1953-1962. doi: 10.1016/j.joen.2017.08.007. Epub 2017 Oct 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain after 6 hours postoperatively	Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10.; 0 reading represents "no pain"; 1- 3 readings represent "mild pain"; 4- 6 readings represent "moderate pain"; 7- 10 readings represent "severe pain"	6 hours postoperatively
Primary	Postoperative pain after 12 hours postoperatively	Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10.; 0 reading represents "no pain"; 1- 3 readings represent "mild pain"; 4- 6 readings represent "moderate pain"; 7- 10 readings represent "severe pain"	12 hours postoperatively
Primary	Postoperative pain after 24 hours postoperatively	Each patient will be given a pain diary based on Numerical Rating Scale(NRS). NRS is an 11-point scale consisting of numbers from 0 through 10.; 0 reading represents "no pain"; 1- 3 readings represent "mild pain"; 4- 6 readings represent "moderate pain"; 7- 10 readings represent "severe pain"	24 hours postoperatively
Secondary	Overall (clinical and radiographic) success after 6 months postoperatively.	Outcome of overall success will be determined based on clinical and radiographic examination. If there is either clinical or radiographic failure , then the case will be considered as an overall failure.	6 months postoperatively
Secondary	Overall (clinical and radiographic) success after 12 months postoperatively.	Outcome of overall success will be determined based on clinical and radiographic examination. If there is either clinical or radiographic failure , then the case will be considered as an overall failure.	12 months postoperatively